Azelastine Hydrochloride and Fluticasone Propionate

Product NDC: 0378-3458
11-digit product format: 003783458
Labeler code: 0378
Product ID: 0378-3458_6e1e173a-2d01-4e67-8361-dd30604bc8aa
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Azelastine Hydrochloride and Fluticasone Propionate
Dosage form: SPRAY, METERED
Route: NASAL
Labeler: Mylan Pharmaceuticals Inc.
Application: NDA202236
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2020-04-14
Marketing end: 2027-02-28
Substance: AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE
Active strength: 137; 50 ug/1; ug/1
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag: No
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N202236-001	DYMISTA	AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD	2012-05-01

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N202236-001	AB

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N202236-001	8168620	2026-02-24		Drug product	2012-05-11
N202236-001	8168620*PED	2026-08-24		Pediatric extension

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N202236-001	DYMISTA	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD	2012-05-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202236-001	DYMISTA	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD	2012-05-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202236-001	DYMISTA	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD	2012-05-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202236-001	DYMISTA	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD	2012-05-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202236-001	DYMISTA	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD	2012-05-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202236-001	DYMISTA	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD	2012-05-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202236-001	DYMISTA	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD	2012-05-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202236-001	DYMISTA	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD	2012-05-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202236-001	DYMISTA	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD	2012-05-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202236-001	DYMISTA	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD	2012-05-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202236-001	DYMISTA	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD	2012-05-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202236-001	DYMISTA	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD	2012-05-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202236-001	DYMISTA	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD	2012-05-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N202236-001	DYMISTA	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD	2012-05-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202236-001	DYMISTA	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2012-05-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N202236-001	DYMISTA	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2012-05-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N202236-001	DYMISTA	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2012-05-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N202236-001	DYMISTA	EQ 0.125MG BASE/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2012-05-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N202236-001	DYMISTA	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2012-05-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N202236-001	DYMISTA	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2012-05-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N202236-001	DYMISTA	EQ 0.125MG BASE/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2012-05-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N202236-001	DYMISTA	EQ 0.125MG BASE/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2012-05-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N202236-001	DYMISTA	EQ 0.125MG BASE/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2012-05-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N202236-001	DYMISTA	EQ 0.125MG BASE/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2012-05-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N202236-001	DYMISTA	EQ 0.125MG BASE/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2012-05-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N202236-001	DYMISTA	EQ 0.125MG BASE/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2012-05-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N202236-001	DYMISTA	EQ 0.125MG BASE/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2012-05-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N202236-001	DYMISTA	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD	2012-05-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N202236-001	DYMISTA	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD	2012-05-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N202236-001	DYMISTA	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2012-05-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N202236-001	DYMISTA	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2012-05-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N202236-001	DYMISTA	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2012-05-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N202236-001	DYMISTA	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2012-05-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N202236-001	DYMISTA	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2012-05-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N202236-001	DYMISTA	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2012-05-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N202236-001	DYMISTA	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2012-05-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N202236-001	DYMISTA	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2012-05-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N202236-001	DYMISTA	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2012-05-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N202236-001	DYMISTA	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2012-05-01	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N202236-001	DYMISTA	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2012-05-01	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N202236-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202236-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202236-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202236-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202236-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202236-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202236-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202236-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202236-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202236-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202236-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202236-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202236-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N202236-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202236-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N202236-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N202236-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N202236-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N202236-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N202236-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N202236-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N202236-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N202236-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N202236-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N202236-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N202236-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N202236-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N202236-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N202236-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N202236-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N202236-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N202236-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N202236-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N202236-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N202236-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N202236-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N202236-001	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 8 · 309 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N202236-001	8168620	2026-02-24		Drug product	2012-05-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202236-001	8168620*PED	2026-08-24		Pediatric extension		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202236-001	8168620	2026-02-24		Drug product	2012-05-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202236-001	8168620*PED	2026-08-24		Pediatric extension		`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202236-001	8168620	2026-02-24		Drug product	2012-05-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202236-001	8168620*PED	2026-08-24		Pediatric extension		`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202236-001	8168620	2026-02-24		Drug product	2012-05-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202236-001	8168620*PED	2026-08-24		Pediatric extension		`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202236-001	8168620	2026-02-24		Drug product	2012-05-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202236-001	8168620*PED	2026-08-24		Pediatric extension		`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202236-001	8163723*PED	2024-02-29		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202236-001	8168620	2026-02-24		Drug product	2012-05-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202236-001	8168620*PED	2026-08-24		Pediatric extension		`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202236-001	8163723*PED	2024-02-29		Pediatric extension		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202236-001	8168620	2026-02-24		Drug product	2012-05-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202236-001	8168620*PED	2026-08-24		Pediatric extension		`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202236-001	8163723*PED	2024-02-29		Pediatric extension		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202236-001	8168620	2026-02-24		Drug product	2012-05-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202236-001	8168620*PED	2026-08-24		Pediatric extension		`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202236-001	8163723*PED	2024-02-29		Pediatric extension		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202236-001	8168620	2026-02-24		Drug product	2012-05-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202236-001	8168620*PED	2026-08-24		Pediatric extension		`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202236-001	8163723*PED	2024-02-29		Pediatric extension		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202236-001	8168620	2026-02-24		Drug product	2012-05-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202236-001	8168620*PED	2026-08-24		Pediatric extension		`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202236-001	8163723*PED	2024-02-29		Pediatric extension		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202236-001	8168620	2026-02-24		Drug product	2012-05-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202236-001	8168620*PED	2026-08-24		Pediatric extension		`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202236-001	8163723*PED	2024-02-29		Pediatric extension		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202236-001	8168620	2026-02-24		Drug product	2012-05-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202236-001	8168620*PED	2026-08-24		Pediatric extension		`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202236-001	8163723*PED	2024-02-29		Pediatric extension		`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202236-001	8168620	2026-02-24		Drug product	2012-05-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202236-001	8168620*PED	2026-08-24		Pediatric extension		`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N202236-001	8163723*PED	2024-02-29		Pediatric extension		`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N202236-001	8168620	2026-02-24		Drug product	2012-05-11	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N202236-001	8168620*PED	2026-08-24		Pediatric extension		`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202236-001	9259428	2023-06-13	U-644		2016-03-09	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202236-001	9901585	2023-06-13		Drug product	2018-03-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202236-001	8163723	2023-08-29	U-644		2012-05-11	`5c6f7cd8ea54…`

Additional Listing Data#

Finished product: Yes
Brand name base: Azelastine Hydrochloride and Fluticasone Propionate

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AZELASTINE HYDROCHLORIDE	137 ug/1
FLUTICASONE PROPIONATE	50 ug/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0L591QR10I	Internal UNII lookup
O2GMZ0LF5W	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1797847	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
7b5cc5a0-0d47-46b5-b5fb-eb9cc248ae9e	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f4fb2f5a-dadb-40e3-a4b1-a2a58f5d9a33	Product name	3	20260126
343e8617-eb68-1e10-cfa9-8c30af285764	Product name	3	20240513
a31ad3df-8021-2ea1-94eb-0fe2f49b7729	Product name	4	20220719
85ee67c3-6973-4172-9ada-b124d28b42f8	Product name	5	20210528
6397aa5d-11e2-42ce-b46f-ac49599ccf00	Product name	5	20201006
033d5d5b-187f-1f40-1e5a-11d732813f92	Product name	4	20200626
813fe018-3e3c-40e4-8f71-7ab50f3dfe81	Product name	2	20180723
3bcd721e-0555-4bc3-96c6-690471ff9d94	Product name	1	20171113
9f9452df-fa34-43d4-97fe-c6605344c5a8	Product name	1	20171113
0e5a25a6-9f05-44b5-8449-aa63e59f7202	Product name	1	20170426
f3c5232f-03de-44f5-996a-90cd9c08bc60	Product name	1	20170426
1cb17fbb-0da4-2841-37bc-e7079783e1a2	Product name	1	20140508
667f427a-8698-a508-767a-53ed61b4c2e9	Product name	1	20140508
6a97ffc8-1d4d-a971-4978-85ba3a22eac9	Product name	1	20140508
6df84e13-2223-fa46-1e26-17e2f58a1e1c	Product name	1	20140508
90fec588-984c-4375-cfd4-7e40114bdf80	Product name	1	20140508
9c1d3c48-b162-204b-f55b-e0f25c31c52e	Product name	1	20140508
9fdb6139-394b-1510-4baf-bde68c419789	Product name	1	20140508
aef26912-037b-9a4e-db49-225ef6dfd8f1	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0378-3458-23	Azelastine Hydrochloride and Fluticasone Propionate	1 in 1 BOX	SPRAY, METERED	1		8
0378-3458-23	Azelastine Hydrochloride and Fluticasone Propionate	120 in 1 BOTTLE	SPRAY, METERED	120		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-3458-23	GM - Gram	0378-3458	ab20276f-246a-41c8-a84d-b23cab5f71a8	1	2020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0378-3458	AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE SPRAY, METERED [MYLAN PHARMACEUTICALS INC.]	7	Current NDC, Legacy NDC, 2 package rows	20250210_7b5cc5a0-0d47-46b5-b5fb-eb9cc248ae9e.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Azelastine Hydrochloride and Fluticasone Propionate	AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE	Mylan Pharmaceuticals Inc.	7b5cc5a0-0d47-46b5-b5fb-eb9cc248ae9e	2024-12-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 202236 application number: NDA202236 ndc (product): 0378-3458
DYMISTA	AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE	Viatris Specialty LLC	4c557ec4-c4cf-11df-851a-0800200c9a66	2024-12-04	Warnings, Adverse reactions	Exact identifier application applno (NDA): 202236 application number: NDA202236

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0L591QR10I	AZELASTINE HYDROCHLORIDE	79307-93-0	AZELASTINE HYDROCHLORIDE
O2GMZ0LF5W	FLUTICASONE PROPIONATE	80474-14-2	FLUTICASONE PROPIONATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1797847	azelastine HCl 137 MCG/ACTUAT / fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal Spray	PSN	7b5cc5a0-0d47-46b5-b5fb-eb9cc248ae9e	8
1797847	azelastine hydrochloride 0.137 MG/ACTUAT / fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal Spray	SCD	7b5cc5a0-0d47-46b5-b5fb-eb9cc248ae9e	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0378-3458-23	00378345823	1 BOTTLE in 1 BOX (0378-3458-23) / 120 SPRAY, METERED in 1 BOTTLE	1 bottle	2020-04-14	2027-02-28	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Azelastine Hydrochloride and Fluticasone Propionate	Mylan Pharmaceuticals Inc.	2024-12-15	HUMAN PRESCRIPTION DRUG LABEL	8